Z-1225-2015Class II

GE Inspection Technologies x|argos 160D system. Cabinet x-ray system

Name: Z-1225-2015 GE Inspection Technologies x|argos 160D system. Cabinet x-ray system
Creator: GE Inspection Technologies, LP
Published: 2015-01-13
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2015-01-13 / Terminated / root cause: design

FDA source

GE Inspection Technologies, LP began a recall of GE Inspection Technologies x|argos 160D system. Cabinet x-ray system on 2015-01-13. FDA classified it as Class II and gives the reason as "It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1225-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-03-20
Terminated: 2015-08-17
Recalling firm: GE Inspection Technologies, LP
Product: GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
Root cause tag: design
FDA root cause: Device Design
Action: GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These corrections will be made free of charge. The Technical Information Letter used for notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter For further questions, please call (717) 447-1278
Quantity in commerce: 2
Distribution: US Distribution to the states of OH and PA.
Product codes and lots: SN - PA1053

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1225-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1211-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-20
Z-1225-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-20

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)